ISO 9001-Clause 5.4

ISO 9001-Clause 5.4  Planning

Clause 5.4.1 Quality objectives

ISO 9001 requirement:

Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1 a), are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
Explanation:

The purpose of quality objectives is to determine conformity to (customer and regulatory) requirements, and effective deployment and improvement of the QMS. Clause 4.1e requires you to measure and analyze QMS processes and clause 7.1 requires objectives for product. Clause 4.2.1a requires you to document it. Clause 8.2.3 and 8.2.4 require you to monitor and measure and evaluate results to your planned objectives. This clause 5.4.1 sets out specific requirements for planning of quality objectives.Top management must provide the leadership, organization and resources to deploy and achieve planned quality objectives. Quality policy  provides the framework for establishing quality objectives in order to be consistent with it and provided examples of such consistency. In this clause, top management must ensure that specific quality objectives are established. Quality objectives is used to measure the performance of products, processes, customer satisfaction, suppliers, use of resources and the overall performance and effectiveness of the QMS. Quality objectives may be established for all QMS processes.

Examples of quality objectives:

  • Product – reduction in defect rates, PPM’s (defective parts per million), scrap rates, rework; improvement in on time delivery (see clause 7.1a).
  • Process – objectives generally focus on improving process productivity through the elimination or reduction of variation and waste in process – inputs, outputs, conversion activity and related use of resources.
  • Monitor and improve process – productivity, reduction of cycle time, errors, omissions and failures; etc. Examples could include objectives for – set-up time, run rates, process cycle time, etc.
  • Customers – reduction in # of complaints, improvement in customer satisfaction rating, on time delivery, service, support, etc,.
  • Suppliers – material defects,on time delivery, no of complaints with supplier.
  • Resources includes facility, equipment, labor, etc.- objectives could be established based on availability, capability, maintenance, personnel competency, absenteeism, production rates; efficiency; safety; etc.
  • For the QMS – customer satisfaction feedback, internal audit results, # of improvement opportunities; etc.

Quality objectives may be set at various functional levels of the organization – top management, departments, processes, functional groups, work cells, project teams, individuals, etc. It would be useful to cover these levels as they add value and contribute to customer or organizational objectives. Employees at all of these levels must be made aware of the importance of and how they must contribute to the achievement of these objectives.Quality objectives must be measurable. Measurement can be done quantitatively or qualitatively. Quantitative measures are generally more objective in determining whether conformity or effectiveness has been achieved. In some situations, the use of qualitative measurements may be appropriate. Objectives based on yes/no criteria, (e.g. – develop new product by March 2006), are also acceptable.
These quality objectives must be deployed and measured and top management must conduct an effective review of the measurement results. These measurement results must also be used for corrective action and continual improvement. The quality objectives must be achieved within a defined time period to ensure accountability. This could be determined by your customer, your management, your head office, regulatory bodies, etc. Your business or quality planning process must establish these time periods and include the communication of objectives and timelines to those responsible for achieving them. Quality objectives may be documented in any or all of these documents  such as quality manual, QMS processes, procedures, quality plans etc. The establishment of quality objectives should be part of the business planning or QMS planning processes. A review of the quality objectives should be part of your management review process. As a quality document, your documented statement of objectives must be controlled by 4.2.3 control of documents. You must be careful not to overwhelm your organization with too many objectives as this may cause more frustration than positive results. Start with objectives that focus on meeting customer requirements and then slowly develop meaningful objectives for key processes and risk prone processes, as initial targets are achieved.

Clause 5.4.2 Quality management system planning

ISO 9001 requirement:

Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1,as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Explanation:

It is the responsibility of top management to provide direction, authorization and, resources and review for QMS planning. When developing your QMS process controls for determining customer requirements, design, development, manufacture, delivery and customer support, you must focus on meeting customer and regulatory requirements as well as the planned QMS objectives established in clause 5.4.1. QMS planning requires you to identify all your QMS processes and describe their sequence and interaction. The criteria and methods for planning, operation and control of these processes come from the rest of the ISO requirements as well as your customer and your own organization.
The continuity and effectiveness of your QMS must be substantially maintained in the event of significant changes in your QMS or organization, e.g. management, ownership, relocation, technology, product, shift in customer base, etc. Changes must be carefully planned so as not to disrupt your organizations ongoing capability and responsibility to effectively meet customer and regulatory requirements
In such instances, change control would require:

  • careful planning of the nature and timeline for the changes;
  •  determining the impact or outcome of such changes;
  •  ensuring adequate resources are available to implement the change;
  •  top management authorization
  •  change deployment and follow-up
  •  review of the QMS by top management after changes are effected.

QMS planning could be a part of business planning or treated as an independent process depending on organizational structure and responsibilities. The management representative typically facilitates QMS planning with the various process owners. The process owners must take responsibility for implementation, maintenance and improvement of their processes. The management representative may provide training and technical assistance as needed. Top management through business planning must provide leadership, resources and review of QMS performance. Performance indicators to demonstrate effective QMS planning could include – achievement of quality objectives; improved customer satisfaction ratings; reduced number and seriousness of internal/external audit non conformities.

Audit Checklist

An audit checklist should cover these areas:
For Clause 5.4.1:-

  • Do Quality Objectives exist? Are they written down?
  • Do they relate/connect directly to your products/services?
  • Are they measurable? Are they being measured? Reported?
  • Does top management ensure that quality objectives are established at relevant functions and levels with the organisation?
  • Are the quality objectives measureable and consistent with the quality policy?
  • Are quality objectives established to ensure that product requirements met?

For Clause 5.4.2:-

  • How are the QMS/ processes planned out?
  • Does the top management ensure that QMS planning is carried out in order to meet requirements given in section 4.1, as well as the quality objectives
  • Does the top management ensure that integrity of the QMS is maintained when changes to the QMS are planned & implemented?
  • Is the output of this planning documented?
  • Are there plans in place to achieve the Quality Objectives? Are the plans documented?
  • Are changes to the QMS implemented in a controlled manner? (As a result of trying to achieve Quality Objectives, have Customer complaints gone up? Returns or credits risen? More  non conforming products or services produced? On-time Delivery performance gone down?)
Mandatory Procedure :

Clause 5.4.1: Not applicable
Clause 5.4.2: Not applicable

Mandatory record:

Clause 5.4.1:Not applicable
Clause 5.4.2:Not applicable

Evidence/ Implementation document ( Not mandatory but helps in fulfillment of requirement):

Clause 5.4.1: Documented statement of Quality objectives
Example of Quality objective includes
Product – reduction in defect rates, PPM’s (defective parts per million), scrap rates, rework; improvement in on time delivery
Process – objectives generally focus on improving process productivity through the elimination or reduction of variation and waste in process – inputs, outputs, conversion activity and related use of resources. Objectives may be used to monitor and improve process – productivity; reduction of cycle time, errors, omissions and failures; etc.
Examples could include objectives for – set-up time; run rates; process cycle time; etc.
Customers – reduction in # of complaints; improvement in customer satisfaction rating; on time delivery; service; support, etc, Suppliers – material defects; on time delivery; # of complaints with supplier.
Resources – (includes facility; equipment; labor; etc.) – objectives could be established based on availability; capability; maintenance; personnel competency, absenteeism; production rates; efficiency; safety; etc.
For the QMS – customer satisfaction feedback; internal audit results; # of improvement opportunities; etc.

pdf Example of functional objectives

Clause 5.4.2:

Evidence could include – achievement of quality objectives; improved customer satisfaction ratings; reduced number and seriousness of internal/external audit nonconformities.

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